: Public Class
Created: 5/21/2010 12:35:10 PM
Modified: 8/30/2019 11:09:33 PM
Project:
Advanced:
DEFINITION:<br/>A variant or snapshot of the study protocol document at a particular point in time.<br/><br/>EXAMPLE(S):<br/>Version 3 of a breast cancer protocol document.<br/><br/>OTHER NAME(S):<br/>Amendment<br/><br/>NOTE(S):<br/>A study protocol document version is one component of the overall concept of a study protocol. The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion and all their associations.<br/>- The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form.<br/>- The StudyProtocolVersion class represents the details of the study protocol that may change over time.<br/>- The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions.<br/>- The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time.<br/><br/>The term "Amendment" needs to be disambiguated since it sometimes refers to the amended version of the protocol (StudyProtocolDocumentVersion) and other times refers to the summary of changes (AmendmentChangeSummaryVersion).<br/><br/>
Attribute
Public ST
  publicDescription
Details:
Map:C3PR=Study.precisText
Map:C3PRv2.9=StudyVersion.descriptionText
Map:caAERSv2.2=Study.descriptionText
Map:CTGOV=Brief Summary
Map:CTOM=Protocol.precisText
Map:CTOM=Protocol.descriptionText
Map:CTRPv1.0=StudyProtocol.publicDescription
Map:CTRPv1.0=InterventionalStudyProtocol.publicDescription
Map:CTRPv1.0=ObservationalStudyProtocol.publicDescription
Map:CTRPv3.8=StudyProtocol.publicDescription
Map:CTRR=Study synopsis
Map:CTRRr3=StudyProtocolDocument.publicDescription
Map:CTRRr3=Study.briefSummary
Map:CTRv1.0=StudyProtocolDocumentVersion.publicDescription
Map:FDA HL7 SD SD DSTU2012=StudyProtocol.text
Map:HSDBv1.0=[Study].Study Public Description
Map:LabViewer2.2=Study.precisText
Notes: DEFINITION:<br/>The textual summary of a document version intended for the general population.<br/><br/>EXAMPLE(S):<br/>The public description of the August 2012 version of E-3108 is "RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public ST
  scientificDescription
Details:
Map:C3PR=Study.descriptionText
Map:C3PRv2.9=StudyVersion.precisText
Map:caAERSv2.2=Study.precisText
Map:CTGOV=Detailed Description
Map:CTRPv1.0=ObservationalStudyProtocol.scientificDescription
Map:CTRPv1.0=StudyProtocol.scientificDescription
Map:CTRPv1.0=InterventionalStudyProtocol.scientificDescription
Map:CTRPv3.8=StudyProtocol.scientificDescription
Map:CTRRr3=Study.detailedDescription
Map:CTRv1.0=StudyProtocolDocumentVersion.scientificDescription
Map:HSDBv1.0=[Study].Study Scientific Description
Map:PSCv2.6=Study.longTitle
Notes: DEFINITION:<br/>The textual summary of a document version that includes extended scientific or technical information.<br/><br/>EXAMPLE(S):<br/>Part of the scientific description of the August 2012 version of E-3108 is "OBJECTIVES: Primary -To correlate CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) of patients with metastatic breast cancer treated with tamoxifen citrate."<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
StudyProtocolVersion
Class   		Name: containingStudyProtocolDocumentVersion
  		Name: containedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyProtocolDocumentVersion always contains one StudyProtocolVersion. Each StudyProtocolVersion might be the contents of one StudyProtocolDocumentVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
StudyProtocolDocumentVersionPublicTitle
Class   		Name: namingStudyProtocolDocVersionPublicTitle
  		Name: namedStudyProtocolDocumentVersion
 
Details:
DESCRIPTION:<br/>Each StudyProtocolDocumentVersionPublicTitle always names one StudyProtocolDocumentVersion. Each StudyProtocolDocumentVersion might be named by one or more StudyProtocolDocumentVersionPublicTitle.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Tag Value
Map:caAERSv2.2 Study
Details:
 
Map:CTRv1.0 StudyProtocolDocumentVersion
Details:
 
Constraint Type Status
is a version of Qualifier Invariant Approved
Details:
For a given StudyProtocolDocumentVersion, the StudyProtocol represented by the StudyProtocolDocument being versioned as the StudyProtocolDocumentVersion must be the same as the StudyProtocol whose StudyProtocolVersion is contained by the StudyProtocolDocumentVersion.<br/>
DocumentAuthor actualIndicator Qualifier Invariant Approved
Details:
Only Person (via HealthcareProvider or ResearchStaff) with actualIndicator = "true" is valid for the DocumentAuthor of a StudyProtocolDocumentVersion.<br/>
Object Type Connection Direction Notes
DocumentVersion Class Generalization To DESCRIPTION: Each StudyProtocolDocumentVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one StudyProtocolDocumentVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):